1. Field
The present invention relates to medical prostheses and to a method and apparatus for performing aneurysm repair, and more particularly to a method and apparatus for performing aneurysm repair by placing a graft percutaneously via an insertion catheter having a controllable inflatable balloon disposed about and integral with its distal end.
2. Prior Art
Aortic aneurysms, or ruptures, are a very common type deteriorating disease which tend to affect blood vessels. Aneurysms often affect the ability of the lumen to conduct fluids and in turn may at times be life threatening. The standard treatment for aneurysms is to surgically remove the aneurysm and graft a replacement prosthetic section into the lumen. However, such surgery is generally postponed until the aneurysm has grown to a diameter greater than five cm. With aneurysms over five cm in diameter, the risk of complications is greater than the risks inherent in surgical excision and grafting of the aneurysm. Consequently, aortic aneurysms, or those that show a rapid increase in size, or those greater than five cm in diameter are generally surgically removed and grafted as a matter of course, before rupture occurs.
The typical procedure for repairing an aortic aneurysm requires one or two days of preparing the large and small intestines prior to hospitalization. The operation itself will generally take one to three hours, and necessitate several units of blood transfusion. The patient commonly remains hospitalized for several days following surgery, and requires as much as three months recuperation time before returning to work. Even for surgical excision and grafting of an aneurysm, there remains significantly high rates of mortality and morbidity. The mortality rate is as high as eight percent (8%). The morbidity rate includes incident complications such as blood loss, respiratory tract infections, wound infections, graft infections, renal failure, and ischemia of the bleeding intestine. The mortality and morbidity rates for this type of major surgery are also often influenced by the fact that the typical aortic aneurysm patient is elderly and therefore less able to withstand major surgery and a major anesthesia.
Another surgical procedure for repairing an aneurysm is to excise part or all of the aneurysm and replace the aneurysmal lumen section with a man made tubular section, sutured end-to-end to the severed lumen at a site proximal to the origination of the aneurysm.
Other methods of repairing aneurysms involve placing graft within the vascular system via catheters through the femoral artery. Conventional tubular aortic replacement sections, however, are generally considerably larger in diameter than the femoral artery and therefore cannot be inserted through the femoral artery lumen. Also, where such devices have been proposed, as in, for example, the devices of U.S. Pat. Nos. 4,140,126 and 4,562,596 by Choudhury and Kornberg, respectively, the expanding structure of the devices are cumbersome, and difficult to operate.
U.S. Pat. No. 5,104,399, to Lazarus discloses an artificial graft and implantation method. Graft is of a preselected cross section and length and is capable of being substantially deformed so as to accommodate the interior surface of the blood vessel as well as stapling means for securing it to the blood vessel. The system further includes a capsule for delivering graft, thereby overcoming some of the complications of the prior art.
The majority of other grafting systems, such as U.S. Pat. Nos. 5,304,220 to Maginot and 5,151,105 to Kwan-Gett, employ a variety of insertion means, but they require additional suturing or other methods for securing graft. Furthermore, once a graft has been placed inside the lumen, adjustment usually requires a major surgical procedure. The difficulties involved with traditional surgical procedures and additional complexities associated with securing grafts make the treatment of aneurysms a very expensive and lengthy procedure.
Thus, there exists a need for a treatment for aneurysms which requires minimal preparation and outpatient care while providing a safe and percutaneous method for implanting grafts which do not require additional suturing or stapling for security.